Author + information
- Received May 27, 2016
- Revision received June 20, 2016
- Accepted June 30, 2016
- Published online October 24, 2016.
- S1936879816310895-29ad3c5e5bdc5ce4f41a5559bfe74983Joo Myung Lee, MD, MPH, PhDa,
- S1936879816310895-c6fd5bcdbb6eeda5f7497a3130e0eb68Jeehoon Kang, MDb,c,
- S1936879816310895-4077bc699ab5c5a3c39b2fe7121c758bEuijae Lee, MDb,
- S1936879816310895-7c6c7d5380ee57efb8031b66510731fbDoyeon Hwang, MDb,
- S1936879816310895-e329fcb0d8e062d3d5cbb3762263e667Tae-Min Rhee, MDb,
- S1936879816310895-d039bb50204cea4363c82386639eb931Jonghanne Park, MD, PhDb,
- S1936879816310895-2377c8743ee07fab37433f8c698a6287Hack-Lyoung Kim, MD, PhDd,
- S1936879816310895-af94579a117fda1ae30425d8e664de76Sang Eun Lee, MD, PhDb,
- S1936879816310895-704092b20c725285eec4228bae8df445Jung-Kyu Han, MD, PhDb,
- S1936879816310895-372fd058b7bfb5f6c2602199a8952d87Han-Mo Yang, MD, PhDb,
- S1936879816310895-55477dd7c0df2c55c94956e69a23862eKyung Woo Park, MD, PhDb,
- S1936879816310895-90524d59bfee43eb43fb70bf601ff4cbSang-Hoon Na, MD, PhDe,f,
- S1936879816310895-362cddaa9417b0ed881036320e0beca1Hyun-Jae Kang, MD, PhDb,
- S1936879816310895-ad8202b0188b2ae72b2c5dea35908ecaBon-Kwon Koo, MD, PhDb,f and
- S1936879816310895-3a1c8669d0badab9c0ab2dd188682f61Hyo-Soo Kim, MD, PhDb,c,∗ ()
- aDivision of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Seoul, Korea
- bDepartment of Medicine, Seoul National University Hospital, Seoul, Korea
- cMolecular Medicine & Biopharmaceutical Science, Graduate School of Convergence Science & Technology, Seoul National University, Seoul, Korea
- dCardiovascular Center, Seoul National University Boramae Medical Center, Seoul, Korea
- eDepartment of Internal Medicine and Emergency Medical Center, Seoul National University Hospital, Seoul, Korea
- fInstitute of Aging, Seoul National University, Seoul, Korea
- ↵∗Reprint requests and correspondence:
Dr. Hyo-Soo Kim, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehak-ro, Jongro-gu, Seoul 110-744, Korea.
Objectives The purpose of this study was to evaluate the clinical impact of chronic kidney disease (CKD) on clinical outcomes in contemporary practice of percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES).
Background Although second-generation DES have improved the safety and efficacy issues in PCI, data regarding the performance of second-generation DES in patients with CKD are still limited.
Methods We performed a patient-level pooled analysis on 12,426 patients undergoing PCI using second-generation DES from the Korean Multicenter Drug-Eluting Stent Registry. Endpoints were stent-oriented outcomes (target lesion failure [TLF]) and patient-oriented composite outcomes (POCO) during a median follow-up of 35 months. CKD patients were stratified by the estimated glomerular filtration rate (eGFR) from mild CKD to end-stage renal disease patients, and by the coexistence of diabetes mellitus (DM).
Results A total of 2,927 patients had CKD (23.6%), who showed a significantly higher risk of TLF (adjusted hazard ratio [HRadjust]: 1.50; 95% confidence interval [CI]: 1.21 to 1.86) and POCO (HRadjust 1.34; 95% CI: 1.17 to 1.55) compared to patients with preserved renal function. Stratified analysis by eGFR showed that TLF was not increased in the mild to moderate CKD, whereas severe CKD and dialysis-dependent patients showed significantly higher risk of TLF (HRadjust 2.44; 95% CI: 1.54 to 3.86; HRadjust 3.58; 95% CI: 2.52 to 5.08, respectively). The eGFR threshold of increased clinical events was 40 to 45 ml/min/1.73 m2. Among CKD patients, DM CKD patients showed a higher incidence of TLF compared to non-DM CKD patients (HRadjust: 1.82; 95% CI: 1.32 to 2.52), driven by the increase in target vessel–related events.
Conclusions In the era of second-generation DES, CKD patients were at a significantly higher risk of clinical outcomes only in severe CKD and end-stage renal disease patients.
- coronary artery disease
- chronic kidney disease
- chronic renal failure
- clinical outcomes
- drug-eluting stent(s)
- percutaneous coronary intervention
Chronic kidney disease (CKD) is a traditional comorbidity with cardiovascular diseases, which increases mortality and morbidity (1). Furthermore, following percutaneous coronary intervention (PCI), CKD is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis, especially in the era of bare-metal stent (BMS) or first-generation drug-eluting stent (DES) (1). Currently, the proportion of CKD patients undergoing PCI is growing due to the high prevalence of coronary artery disease in these patients and the rapid increase of risk factors, such as old age, diabetes, and hypertension (1,2). However, only a few studies have been conducted on sole CKD patients, and CKD patients have been often excluded from randomized controlled trials based on the concerns of increased adverse events and low procedural success rates (3).
Based on previous study results, current guidelines (2014 European Society of Cardiology/European Association for Cardio-Thoracic Surgery guideline) recommend DES implantation over BMS (Level of Evidence Class IB) (4). These studies compared BMS and first-generation DES in CKD patients (3,5), whereas in real-world practice, these stents have been replaced by second-generation biocompatible or biodegradable-polymer coated stents due to the superior efficacy and safety (6). However, the usage of second-generation DES in CKD patients has not been fully evaluated. Furthermore, whether the CKD severity would differentially influence clinical outcomes after PCI with second-generation DES is also unknown. A few previous studies were inconclusive due to the limited sample size (2,7–9), only to leave limited evidence of this issue.
Therefore, we sought to evaluate the clinical impact of CKD stratified by severity, on clinical outcomes in contemporary practice of PCI with second-generation DES, using the patient-level pooled data from the Korean Multicenter Drug-Eluting Stent Registry, which is the largest cohort compared to previous studies.
Extended description of study methods are presented in Online Appendix.
Pooled patients population
The analysis population of this study was from the multicenter registries in Korea, which were dedicated registries for second-generation biocompatible or biodegradable-polymer coated DES. There were no exclusion criteria in all registries except for the patient’s withdrawal of consent. Among the total pooled population of 12,575 patients, those with no serum creatinine value were excluded for the current analysis (Figure 1).
Therefore, the analyzed sample size was 12,426 patients, who were enrolled from a total of 57 participating centers in Korea (72.2% of the total PCI centers in Korea; the participating centers and investigators are listed in the Online Appendix). The study protocol was approved by the ethics committee at each participating center and was conducted according to the principals of the Declaration of Helsinki. All patients provided written informed consent.
Definition and classification of chronic kidney disease
The CKD was defined as a decreased eGFR <60 ml/min/1.73 m2, calculated by the 4-component MDRD (Modification of Diet in Renal Disease) study equation incorporating age, race, sex, and serum creatinine (10). The serum creatinine level immediately before the index procedure was used to calculate baseline eGFR before index procedure. Patients were classified into 5 groups according to the renal function; the preserved renal function group (eGFR <15 ml/min/1.73 m2), mild CKD group (eGFR 45 to 59 ml/min/1.73 m2), moderate CKD group (eGFR 30 to 44 ml/min/1.73 m2), severe CKD group (eGFR 15 to 29 ml/min/1.73 m2), and dialysis-dependent group (end-stage renal disease [ESRD], eGFR <15 ml/min/1.73 m2). We also stratified the population according to blood urea nitrogen tertile, to validate the effect of uremia on clinical outcomes. The combination of CKD and diabetes mellitus (DM CKD) was defined according to guidelines “The Kidney Disease: Improving Global Outcomes and American Diabetes Association” (11).
Follow-up, data collection, and analysis
Data of the Korean Pooled Drug-Eluting Stent Registry was constructed using a Web-based reporting system from all 5 registries. All the 5 registries used the same definition of included variables. For any clinical event, all relevant medical records were reviewed and adjudicated by an external clinical event adjudication committee. Among the total pooled population, 417 patients (3.3% of 12,575 patients) were lost to follow-up; however, the vital status of these patients was assessed using the National Insurance System by the Korean government. The median follow-up duration was 1,046 days (interquartile range: 395 to 1,096 days).
Outcomes and definitions
The primary outcome was target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI) (not clearly attributed to a nontarget vessel), and a clinically indicated target lesion revascularization (TLR). The key secondary outcome, the patient-oriented composite outcome (POCO), included all-cause mortality, any MI (including nontarget vessel territory), and any revascularization. The nontarget lesion–related composite events were defined as a composite of any cardiac death, which was not clearly attributable to target vessel–related events, nontarget vessel MI, and nontarget lesion repeat revascularization. All deaths were considered cardiac unless an undisputed noncardiac cause was present. MI was defined according to the Academic Research Consortium definitions and an extended historical protocol definition. Other secondary outcomes included individual components of TLF and POCO and stent thrombosis (ST) defined as definite, probable, or possible, according to the Academic Research Consortium definitions.
Event rates were calculated based on Kaplan-Meier censoring estimates, and the log-rank test or the Breslow test was used to compare survival cures between groups. To evaluate the independent effect of CKD on clinical outcomes, multivariable-adjusted Cox proportional hazard model analysis was performed using covariates, which showed difference in their distribution between patients with or without CKD, presented in Table 1. As a sensitivity analysis, multivariable-adjusted Cox proportional hazard model analysis was also stratified according to the participating centers.
Also, for the impact of CKD severity on clinical outcome, a multivariable-adjusted Cox proportional hazards model was applied to compare risk of adverse events in subgroups according to CKD severity or the presence of DM CKD or non-DM CKD. The adjusted variables were presented in the Online Appendix. In comparison of clinical outcomes among DM CKD, non-DM CKD, and preserved renal function group, DM was removed from the covariates list of multivariable adjustment. The unadjusted and adjusted hazard ratios (HR) with 95% confidence interval (CI) were presented as summary measures. The proportion hazards assumptions in the Cox proportional hazards models were graphically inspected in the “log minus log” plot and were also confirmed with tests of nonzero slope in a generalized linear regression of the scaled partial residuals on survival time. All the Cox proportional hazards models for clinical outcomes presented in the manuscript met the assumption of proportional hazards.
To explore the optimal outcomes-based threshold of eGFR to predict increased risk of TLF or POCO, probability of the risk was estimated using the multivariable Cox proportional hazards model and was plotted using the locally weighted scatterplot smoothing (LOWESS) regression line according to eGFR values. The threshold of eGFR was determined at the intersection point of the LOWESS line and the pre-defined event rates of the preserved renal function group.
In addition, multivariable Cox regression analysis was also used to explore independent predictors of TLF in CKD patients. C-statistics with 95% CI were calculated to validate the discriminant function of the model. All probability values were 2-sided and p values <0.05 were considered statistically significant.
Patient and lesion characteristics of the korean pooled drug-eluting stent registry
Of the total population of 12,426 patients (17,350 lesions), 2,927 patients (23.6%; 4,440 lesions [25.6%]) were CKD patients and 9,499 patients (76.4%) had preserved renal function. Among CKD patients, 79.6% had mild to moderate CKD and 20.4% had severe CKD or ESRD. The baseline characteristics of patients and lesions are shown in Table 1 and Online Table 1, respectively. Off-label indication of DES implantation was performed in 74.2%, multivessel intervention was in 18.0%, and type B2 or C lesion composed of 71.5% of the lesions. Despite the high risk profile, the procedural success rates were consistently over 98%. Discharge medication showed that most patients received dual-antiplatelet agents with adequate secondary prevention (i.e., high prescription rates of statins, beta-blockers, and renin-angiotensin-aldosterone system blockage agents).
Clinical outcomes of CKD patients after PCI with second-generation DES
The cumulative incidence of TLF and POCO and the individual components, between CKD patients and those with preserved renal function are shown in Figure 2 and Online Figure 1. CKD patients showed significantly higher incidence of TLF (11.9% vs. 4.9%; p < 0.001) and POCO (22.2% vs. 12.9%; p < 0.001). An adjusted HR for individual components of TLF and POCO showed that CKD patients were at excess risk of all-cause death, cardiac death, any MI, and any revascularization, whereas risks of target vessel MI and TLR were comparable to those with preserved renal function patients (Table 2). Stratified analysis according to participating centers also showed similar results (Online Table 2). The excess risk of any MI in CKD patients was mainly driven by nontarget vessel MI. Regarding definite or probable ST, CKD patients had a numerically higher risk of ST, and landmark analysis showed most of the ST events occurred during the first 30-day from index procedure. However, after multivariable adjustment, adjusted HR did not reach statistical significance for both the total follow-up period and initial 30-day period (Online Figure 2, Table 3).
Among CKD patients, independent predictors of TLF by multivariable Cox regression analysis are presented in Table 3. Left main or 3-vessel disease lesions and multivessel PCI were lesion-related factors, and clinical risk factors included old age, male gender, peripheral vascular disease, DM, and clinical presentation of acute myocardial infarction.
Clinical outcomes after PCI with second-generation DES, according to the CKD severity
Figure 3 and Table 4 demonstrate the cumulative incidence of clinical outcomes, according to the CKD severity. The incidence of TLF (4.9% vs. 8.6% vs. 12.5% vs. 21.8% vs. 24.1%; p < 0.001) and POCO (4.9% vs. 8.6% vs. 12.5% vs. 21.8% vs. 24.1%; p < 0.001) gradually increased along with CKD severity. After multivariable adjustment, severe CKD and ESRD patients had significantly higher risk of TLF and POCO, whereas mild to moderate CKD patients had a comparable risk of TLF or POCO compared to those with preserved renal function. Similarly, the composite events of target vessel MI or TLR were also significantly increased only in ESRD population. Additionally, only patients with highest tertile of blood urea nitrogen level had significantly higher risk of 3-year clinical endpoints, compared with lowest tertile group (Online Table 3). Within CKD patients, the risk size of TLF and POCO in severe CKD and ESRD patients were 2- to 3-fold higher than that in mild to moderate CKD patients. To draw a cutoff value of eGFR to predict the clinical outcomes, we plotted the multivariable-adjusted predicted rates of TLF and POCO according to eGFR, with the pre-defined TLF rate (4.9%) and POCO rate (12.8%) in patients with a preserved renal function. For both TLF and POCO, the LOWESS-fitted curve crossed the pre-defined event rate at an eGFR of 40 to 45 ml/min/1.73 m2 (Figure 4).
Pattern of clinical events according to type of CKD
Among CKD patients, 1,496 (51.3%) were DM CKD patients. The DM CKD group showed highest cumulative incidence of TLF (14.9% vs. 8.6% vs. 4.9%, for DM CKD, non-DM CKD, and preserved renal function group, respectively; p < 0.001) and POCO (26.1% vs. 18.0% vs. 12.9%; p < 0.001) (Online Figure 3). After adjustment of comorbidities, DM CKD patients showed a higher risk of TLF (HR: 1.82; 95% CI: 1.32 to 2.52; p < 0.001) and POCO (HR: 1.50; 95% CI: 1.20 to 1.87; p < 0.001) compared to non-DM CKD patients. TLF was mainly driven by cardiac death and TLR (Online Table 4).
We also analyzed outcomes of target- versus nontarget lesion–related events by DM CKD. Both target- and nontarget lesion–related events gradually increased in patients with preserved renal function, non-DM CKD, and DM CKD (target lesion related: 4.9% vs. 8.6% vs. 14.9%; p < 0.001; nontarget lesion related: 8.3% vs. 10.1% vs. 13.1%; p < 0.001). Especially, the incidence of target-lesion related events showed a rapid increase, composing 38.0% of the total events in the preserved renal function group, 47.8% of the total events in non-DM CKD patients, and increased to 57.1% in DM CKD patients (Figure 5).
In this study, we performed a patient-level pooled analysis of 12,426 patients in the Korean Multicenter Drug-Eluting Stent Registry and explored the clinical impact of CKD in the era of second-generation DES. First, we demonstrated that CKD patients showed significantly higher risk of TLF and POCO than those with preserved renal function. The excess risk of TLF was mainly driven by higher risk of cardiac death. Interestingly the risk of stent-failure itself (including target vessel MI, TLR, or definite or probable ST) was similar between CKD and non-CKD patients. Second, regarding the CKD severity, mild to moderate CKD patients did not have a significantly higher risk of TLF or POCO than the preserved renal function group. In contrast, the risk of TLF or POCO in patients with severe CKD or ESRD was 2- to 3-fold higher than in those with mild to moderate CKD. The cutoff value of eGFR to predict adverse outcome after PCI using a second-generation DES was 40 to 45 ml/min/1.73 m2. Last, among CKD patients, DM CKD showed a worse outcome compared to non-DM CKD patients. Also, unlike patients with preserved renal function patients and non-DM CKD patients, target-lesion related events composed of more than one-half of total events in DM CKD patients.
Changing paradigm of clinical events in CKD patients in the new ERA of second-generation DES
CKD patients are known to have a more extensive coronary arterial disease with more complexity, than those without CKD (1,12). In addition, CKD is a well-known major independent predictor of adverse cardiovascular events after PCI (7,12–15). Although first-generation DES significantly reduced rates of stent failure compared with BMS, patients with CKD still showed significantly a higher rate of TLR or definite or probable ST than those with preserved renal function (15,16). However, previous evidences were generated from BMS or first-generation DES, which cannot reflect contemporary real-world practice of PCI. Furthermore, previous trials on second-generation DES, which have shown superior efficacy and safety compared to first-generation DES, had a very low (<3%) or unreported proportion of CKD patients (17–22). A few previous studies (2,7–9) did evaluate the efficacy of second-generation DES in CKD patients, however, several limitations precluded unbiased interpretation, such as the small sample size, lack of long-term follow-up results, and heterogeneous results across the studies. The RENAL-DES (Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease) trial firstly demonstrated a significantly lower risk of 1-year ischemia-driven target vessel revascularization in the second-generation everolimus-eluting stent (EES) group compared to the BMS group in 215 patients with CKD (9). However, the small number of patients with severe CKD (n = 54, 25.1%), and the exclusion of high-risk patients (i.e., left main disease, in-stent restenosis, or acute ST-segment elevation MI) limits the results to be generalized to real-world practice (9). Another recent post hoc analysis of the PRODIGY (Prolonging Dual-Antiplatelet Treatment after Grading Stent-induced Intimal Hyperplasia Study) trial also showed enhanced safety and efficacy of second-generation DES in CKD patients, compared with BMS or first-generation DES. Nonetheless, the proportion of severe CKD or dialysis-dependent patients was too limited to be generalized (23).
In this regard, we demonstrated the long-term clinical outcomes of PCI using second-generation DES in CKD patients, from the Korean Multicenter Drug-Eluting Stent Registry, a large unrestricted populations reflecting real-world practice. From our cohort, we could find a higher risk of nontarget lesion–related outcomes in CKD patients, rather than stent-related or target lesion-related events. This may be explained by the intimate association between impaired renal function and progression of atherosclerosis (24). Furthermore, this association is supported by recent invasive imaging studies, which compared nontarget vessel plaque characteristics. (25,26). Kato et al. (25) compared optical coherence tomography–measured plaque characteristics of nontarget vessel stenosis in CKD patients and non-CKD patients. They presented that nontarget vessel plaques in CKD patients showed significantly a higher lipid index (mean lipid arc × lipid length), a higher prevalence of calcification, cholesterol crystal, and plaque disruption, compared with nontarget vessel plaques in non-CKD patients. Kashiyama et al. (26) also presented serial coronary plaque change of nontarget vessel lesions by integrated backscatter intravascular ultrasound, according to severity of CKD. In their results, patients with CKD stages 3 to 5 showed serial increase of plaque burden, plaque volume, and lipid and fibrous plaque volumes despite optimal medical treatment. These results stress the clinical implication of secondary prevention for systemic atherosclerosis and comorbidities in CKD patients.
Differential impact on clinical features according to CKD severity
Several previous studies have evaluated the relationship between lower eGFR and adverse cardiovascular events after PCI using BMS or first-generation DES (13,14,27,28). These studies uniformly showed an increase of adverse events as renal function deteriorated even in patients with mild renal impairment, in the first-generation DES era. However, in our study, we could find new and intriguing results from a stratified analysis according to CKD severity. Adverse cardiovascular events were not increased in mild or moderate CKD patients, whereas only severe CKD or ESRD patients were at a significantly higher risk of TLF or POCO. Furthermore, the statistically calculated threshold of eGFR as a cutoff value to predict adverse events was 40 to 45 ml/min/1.73 m2.
These results were in line with the recently published propensity score matched analysis by Bangalore et al. (29), which compared second-generation EES versus coronary artery bypass graft surgery (CABG) in CKD patients. In this study, CKD patients who underwent either PCI with EES or CABG for multivessel coronary artery stenosis were followed up for a median of 2.7 years. The event rates in the EES group could be indirectly compared according to severity of CKD (eGFR 45 to 60 ml/min/1.73 m2 vs. eGFR <45 ml/min/1.73 m2 vs. dialysis-dependent patients). Dialysis-dependent patients showed the highest risk of all the clinical events such as all-cause mortality (14.4% vs. 21.7% vs. 54.3%), any MI (7.6% vs. 8.6% vs. 31.9%), and any revascularization (24.9% vs. 22.3% vs. 48.3%) than did patients with mild or moderate CKD.
Considering these results, we could conclude that second-generation DES do better in CKD patients, whereas those with eGFR <40 to 45 ml/min/1.73 m2, and especially dialysis-dependent patients (ESRD), still remain as the most vulnerable subset, needing meticulous caution regarding the revascularization strategy and follow-up care.
Different pattern of clinical outcomes in patients with DM and CKD
Diabetes is the leading cause, and is simultaneously a risk factor itself for cardiovascular disease. Previous studies have shown that combination of diabetes and CKD is a potent predictor of adverse cardiovascular events (30,31). In this study, we evaluated a large population of DM CKD (n = 1,496) and non-DM CKD (n = 1,418), and not only did DM CKD patients have a higher event rate of TLF and POCO, but also we could find a unique pattern of clinical events. Although clinical events in non-DM CKD patients were mainly due to “nontarget” lesion–related events, DM CKD patients showed a similar distribution of both target and nontarget lesion–related events. We can assume that DM over CKD might have induced additive hazard of problems in the stented segment along with accelerated progression of de novo lesions, as also presented in previous study (32).
There are several important considerations when interpreting the study results. First, we should consider the inherent limitations of nonrandomized comparisons such as allocation bias, uneven distribution of risk factors, and possibility of unmeasured confounders. Second, the incidences of clinical events, especially in MI, were relatively lower than previous studies. Although the possibility of under-reporting of the events could not be neglected, it has been consistently reported that the incidence of MI is substantially lower in Asian populations than in Western populations (18,33). Third, we focused on the clinical impact of CKD in contemporary PCI using second-generation DES, and therefore the lack of an appropriate comparator, such as such as medical treatment, first-generation DES, or CABG, makes inferences incomplete.
In the era of second-generation DES, mild to moderate CKD did not show significantly higher clinical events after PCI, whereas severe CKD or ESRD patients still showed significantly higher TLF or POCO than did non-CKD patients, which was mainly driven by nontarget lesion–related events. DM CKD patients had higher event rates compared to non-DM CKD patients, mostly due to the increase of target lesion–related events in DM CKD patients.
WHAT IS KNOWN? CKD is a traditional high-risk comorbidity that increases cardiovascular mortality and morbidity, and it has been known to be associated with adverse cardiovascular outcomes including restenosis or ST following PCI, especially in the era of BMS or first-generation DES. In real-world practice, second-generation biocompatible or biodegradable polymer–coated stents have replaced first-generation DES, owing to the better efficacy and safety issues. However, there is very limited evidence on the performance of second-generation DES in CKD patients.
WHAT IS NEW? From the current study that evaluated the largest sample size of CKD patients, CKD patients had higher incidence of adverse events after PCI with second-generation DES than did the non-CKD population, mainly due to nontarget lesion–related events. This may be explained by the intimate association between impaired renal function and progression of atherosclerosis, and stressed the clinical importance of systemic control for atherosclerosis and comorbidities in CKD patients. Regarding the severity of CKD, mild to moderate CKD patients had similar risk of adverse events to that of non-CKD patients, whereas only severe CKD and ESRD patients were at an increased risk of clinical events. The statistically calculated threshold of eGFR as an outcome-based cutoff value to predict adverse events was 40 to 45 ml/min/1.73 m2.
WHAT IS NEXT? Although second-generation DES has improved the clinical outcomes in mild to moderate CKD patients, severe CKD and ESRD patients are still the most vulnerable candidates in contemporary practice. Selecting optimal PCI candidates and medical treatment strategies to minimize adverse clinical events in these patients is an important issue to be solved. Also, to determine the appropriate revascularization method, comparison of clinical outcomes between PCI with second-generation DES and coronary artery bypass graft surgery in severe CKD and ESRD patients should be further clarified.
For expanded Methods and reference sections as well as supplemental tables and figures, please see the online version of this article.
This study was supported by a grant from the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (HI14C1277) and a grant from the Innovative Research Institute for Cell Therapy, Seoul National University Hospital (A062260), sponsored by the Ministry of Health, Welfare & Family, Korea. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Lee and Kang contributed equally to this work.
- Abbreviations and Acronyms
- bare-metal stent(s)
- confidence interval
- chronic kidney disease
- drug-eluting stent(s)
- diabetes mellitus
- everolimus-eluting stent(s)
- estimated glomerular filtration rate
- end-stage renal disease
- locally weighted scatterplot smoothing
- percutaneous coronary intervention
- patient-oriented composite outcome
- target lesion failure
- Received May 27, 2016.
- Revision received June 20, 2016.
- Accepted June 30, 2016.
- American College of Cardiology Foundation
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